K-number	K192238
Device name	AC3 Series Intra-Aortic Balloon Pump (IABP)
Applicant	Arrow International, Teleflex
Product code	DSP
Device class	Class II
Decision date	Nov 12, 2019
Decision	Substantially Equivalent
Regulation	870.3535

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Source

View the full FDA submission: accessdata.fda.gov

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AC3 Series Intra-Aortic Balloon Pump (IABP)

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